Gennova recently secured marketing authorisation of tenectaplase for stroke patients in India, the first such use of the drug anywhere in the world.Vikas Dandekar | ET Bureau | Updated: August 18, 2016, 08:18 IST

German giant Boehringer Ingelheim battles India's Gennova Biopharma over stroke treatmentMUMBAI: Can a biological drug prescribed worldwide for heart attacks also be approved for use in stroke treatment? That’s the point of dispute between global pharmaceutical powerhouse Boehringer Ingelheim and Gennova Biopharma, the biotech arm of Pune-based Emcure Pharma.

Gennova recently secured marketing authorisation of tenectaplase for stroke patients in India, the first such use of the drug anywhere in the world. But the German giant has disputed the grounds on which Indian drug regulator gave approval. It has sent letters to doctors cautioning that tenectaplase is approved and used globally only in heart attacks, or myocardial infarction to use the medical term.

In India, Boehringer Ingelheim sells tenectaplase under the brand name Metalyse for heart attack patients as part of a licensing deal with Roche-Genentech. For strokes, it sells Actilyse, which is the drug alteplase, considered the gold standard in treating the condition.

Amyocardial infarction stops blood flow to a part of the heart while a stroke halts it to the brain. Amid the prospects of a longdrawn dispute, Gennova has said it will price its new drug at Rs 28,900 for a course of therapy, cutting the cost of current treatment for strokes dramatically from about Rs 70,000 for a similar dose of alteplase, based on the maximum retail price.Boehringer Ingelheim told doctors that the evidence for the benefits of tenectaplase in stroke patients is “scanty” and that no “fullfledged, sufficiently powered study” comparing tenectaplase with alteplase has been completed anywhere in the world. A Boehringer Ingelheim spokesperson noted the Indian approvals were based on a small, open-label, non-comparative trial.

“None of the worldwide stroke bodies including American Stroke Association, European Stroke Organisation, American Academy of Neurology and Indian Stroke Association recommend the use of tenectaplase for acute ischemic stroke in their guidelines,” Boehringer Ingelheim India Managing Director Sharad Tyagi told ET.

Gennova strongly countered those views. In a detailed statement, it informed ET that the approval by India’s high-powered subject expert committee was obtained following completion of mandatory trials in more than 100 patients and was the culmination of rigorous scientific efforts that spanned nearly a decade.

The Pune-based drug maker added it had presented ample, superior-quality evidence for use of the drug on stroke patients and will bolster this with exhaustive clinical studies on a larger set of people. Gennova said it also plans to showcase its findings in international conferences and reputed journals.

CLEARED BY PANEL OF NEUROLOGISTS

In July, a committee of high-level neurologists drawn from leading medical institutes under the health ministry recommended marketing authorisation of tenectaplase for strokes. As a measure of caution, it also directed Gennova to conduct active post-marketing surveillance for safety evaluation of 1,000 patients, in accordance with the best international clinical practices.

The committee set another rider for Gennova. The company has to submit data of the first 500 patients to the Drug Controller General of India (DCGI) for additional evaluation by the committee. Notably, last September, the expert committee had sided with the Indian Stroke Association, which raised concerns primarily over the number of patients in the clinical trial protocol to test tenectaplase use in stroke treatment. The committee had then asked Gennova to resubmit a new protocol with proper justification. Gennova said it had complied with the requirements of the expert committee and met all conditions to DCGI’s satisfaction.

A Boehringer Ingelheim spokesperson said the current regulatory guidelines for similar biologics and the rules set for biomedical research by the Indian Council of Medical Research clearly state that a new drug or a new indication required one or multiple confirmatory clinical trials in comparison with the current standard of care worldwide.

Gennova noted that it had developed its clinical trial protocol in consultation with medical professionals and that no demand had been made by the regulatory authority to conduct any kind of comparative trial for the indication expansion of tenectaplase for use in stroke patients. In 2006, Gennova highlighted the precedent of a single-arm study of alteplase in stroke patients. A Japanese group conducted a single-arm study in 103 patients and received approvals from one of the world’s most stringent regulatory bodies, it said. These refer to trials using a specific treatment rather than randomised studies